Boston, MANCT05683418Now EnrollingIRB Ready

HR+/HER2-negative Breast Cancer Clinical Trial in Boston, MA

Access cutting-edge hr+/her2-negative breast cancer treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Totus Medicines

Quick Self-Assessment

See if you qualify for this Boston location

Preparing your pre-screening questions…

Expert Care in Boston

Access hr+/her2-negative breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hr+/her2-negative breast cancer treatment provided free

Apply for This Boston Location

Check if you qualify for this hr+/her2-negative breast cancer clinical trial in Boston, MA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This HR+/HER2-negative Breast Cancer Study in Boston

The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria. The main questions it aims to answer are: 1. Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2? 2. Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day? 3. Phase 1b: how safe and effective is TOS-358 when given with standard of care medicines for HR+HER2- metastatic breast cancer (fulvestrant and CDK4/6i)

Sponsor: Totus Medicines

Who Can Participate

Inclusion Criteria

Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
Up to 3 prior lines of therapy for metastatic disease
Willing and able to provide written informed consent for this study
Adults ≥ 18 years old at time of consent
Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test
Measurable or evaluable disease by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥ 6 months, as determined by the investigator
Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product
Fasting plasma glucose \<= 140 mg/dL AND hemoglobin A1c (HbA1c) \<= 7.0%
Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test Key

Exclusion Criteria

Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2
Known active central nervous system (CNS) metastases
PTEN mutations

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05683418) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HR+/HER2-negative Breast Cancer Treatment Options in Boston, MA

If you're searching for hr+/her2-negative breast cancer treatment options in Boston, MA, this clinical trial (NCT05683418) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hr+/her2-negative breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hr+/her2-negative breast cancer clinical trials near you to find additional studies recruiting in your area.

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See all breast cancer clinical trials recruiting in Boston — not just this study.

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